While the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act) only makes a minor change to add sesame as a major food allergen, it signals the government’s intent to closely examine food allergen restrictions and broaden their scope. The FASTER Act, signed into law on April 23, 2021, adds sesame to the Federal Food, Drug, and Cosmetic Act's list of major food allergens. Previously, “major food allergen” referred to eight ingredients: milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans [21 U.S.C. § 321(qq)]. Sesame is now part of this list, rounding out the “big nine.” These nine ingredients are considered the most dangerous due to the number of people who are allergic to them and the severity of the reactions they can produce.
The effect of this change is most notable in how manufacturers label their products, as the Federal Food, Drug, and Cosmetic Act requires manufacturers to clearly label major food allergens. Starting on January 1, 2023, this requirement will apply to products that contain sesame in any form. According to the non-profit Food Allergy Research & Education, sesame can appear in undeclared ingredients such as flavors or spice blends. In these situations, the FASTER Act would require that sesame be called out and listed as a food allergen. Manufacturers can satisfy the act’s labeling requirements in one of two ways:
1) including a statement “printed immediately after or adjacent to the list of ingredients” that includes the word “contains” followed by “the common or usual name of the major food allergen.” [21 U.S.C. § 343(w)(1)(A)].
2) listing the major food allergen as an ingredient which, with certain exceptions, must be “followed in parentheses by the name of the food source from which the major food allergen is derived.” [21 U.S.C. § 343(w)(1)(B)].
Manufacturers who do not comply with these requirements open themselves to government enforcement action and to civil liability. The U.S. Food and Drug Administration (FDA) regularly issues warning letters to food manufacturers who do not comply with this provision. For example, in a December 2020 warning letter to Whole Foods, FDA stated that it had determined that Whole Foods had “engaged in a pattern of receiving and offering for sale misbranded food products.” FDA warned Whole Foods that “failure to promptly correct these violations” could result in FDA taking “enforcement action,” including “seizure and/or injunction.”
In addition to federal government enforcement action, failure to comply with food labeling laws may also lead to civil lawsuits. Less than a week after FDA sent Whole Foods the warning letter, a plaintiff filed a class action lawsuit in the Southern District of New York. The complaint cites extensively to the warning letter and demands injunctive relief. Plaintiffs sued under both federal and New York law, and the specific claims included breach of express warranty and implied warranty of merchantability, negligent misrepresentation, fraud, and unjust enrichment. To avoid these costly enforcement and civil actions, manufacturers should carefully examine their ingredients and labels to ensure compliance with this statute.
However, adding sesame as a major food allergen appears to be just the beginning of changes to food allergy laws. The FASTER Act requires the Secretary of Health and Human Services to submit a report with recommendations for the “timely, transparent, and evidence-based modification of the definition of ‘major food allergen’” in the Federal Food, Drug, and Cosmetic Act. The Secretary must also provide recommendations about scientific criteria (such as “the prevalence or severity of allergic reactions” to an ingredient) that would be required to add the ingredient to the list of major food allergens as well as recommendations about “opportunities for stakeholder engagement and comment.” This direction to Health and Human Services to evaluate further changes to the definition of “major food allergen” and the standards to qualify as one strongly suggests additional foods will be added to this list moving forward, although it does not provide any insight into what foods these might be.
The regulatory frameworks of other countries could provide some insight into this question. The EU, for example, currently requires 14 ingredients to be labeled as major allergens, including mustard; celery; cereal containing gluten; lupin (a legume seed); and mollusks. Canada also includes mustard and mollusks in its list of major allergens. The U.S. followed the EU and Canada by including sesame in its allergen list—we can expect that it might do the same with some of the other ingredients these regulatory agencies consider to be major allergens. Mustard seeds, for example, could be a likely next addition—it is a major food allergen in both the EU and Canada and the American College of Allergy, Asthma, and Immunology considers it a common allergy trigger.
For most manufacturers, the addition of sesame or any other ingredient to the major food allergen list will not present much of a logistical challenge. It is likely that manufacturers are already listing other ingredients in compliance with the Federal Food, Drug, and Cosmetic Act and will only need to modify the labels to include sesame and any other ingredient that may be added to the major food allergens list. However, manufacturers should closely track the Health and Human Services’ report that is likely to suggest additional changes to food allergen laws to keep ahead of new developments in this rapidly evolving area of law.
Kelly Matayoshi, J.D., is a partner and MaryJo Lopez, J.D., is an associate in Farella Braun + Martel’s Consumer Products & Manufacturing Industry Group. Farella is a law firm headquartered in San Francisco.
